Early Intervention to Reduce Bone Loss After Spinal Cord Injury

Not Applicable

• Conditions: Osteoporosis; Spinal Cord Injury
• Interventions: Device: Whole body vibration (WBV)

• Registration Number: NCT02334410
• Lead Sponsor: University of Strathclyde

Brief Summary

After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. It has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous longitudinal study, in which we described rates of bone loss in the first year of SCI using peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and "red-flag" those patients at highest risk of rapidly weakening bones. We propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before BMD reaches dangerously low values. In this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. If shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with SCI.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-01-06
• Last Update Submitted: 2015-01-06
• Study First Posted: 2015-01-08
• Last Update Posted: 2015-01-08
• Study Start: 2015-02
• Primary Completion: 2018-01
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Motor-complete spinal cord injury (SCI)
• SCI at neurological levels C4 and below
• Within six weeks of SCI

Exclusion Criteria

• Recent bilateral fractures in tibia and/or femur
• Previously diagnosed osteoporosis
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole body vibration (WBV)	Whole body vibration (WBV)	Vibration therapy

Primary Outcome Measures

Name	Time	Method
Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans	12 months	Can WBV intervention reduce the rate of bone loss in patients with early spinal cord injury?
Rate of change of calcium and bone profiles based on blood samples	12 months	Biochemical markers of bone formation, bone resorption, hormone and mineral levels.

Secondary Outcome Measures

Name	Time	Method
Correlation between imaging and biochemical markers of bone health	12 months	Imaging-derived data will be compared with analyses of blood samples as indicators of bone health

Trial Locations

Locations (1)

Queen Elizabeth National Spinal Injuries Unit; 🇬🇧 Glasgow, United Kingdom